Date: 19 June, 2023
Time: 17:00 – 17:45 CEST | 11:00 – 11:45 AM EST | 8:00 – 8.45 AM PDT
Location: Virtual
Language: English
Introduction
Manufacturers are responsible for ensuring medical devices meet all applicable requirements of the (EU) 2017/745 Medical Devices Regulation (MDR) prior to them being placed on the European market. technical documentation(s) is required for all classes of devices and all but class I technical documentation must be evaluated by a Notified Body.
In this webinar, attendees will learn ways to minimize the pain of getting your technical documentation through the review performed by the Notified Body.
Learning Objectives
- Learn about pitfalls when submitting your technical documentation for approval and suggestions on how to avoid them
- Common areas of questions from Notified Bodies regarding your technical documentation and examples of the tools we will use to minimize the chance of questions from the Notified Body
- How our services can support your technical documentation and QMS submissions
Who should attend?
Regulatory specialists, experts, managers, directors- QA specialists, experts, managers, directors
- PRRC
- Project managers
- Managers with strategic decision making
- Start-ups
The webinar closes with a 15-minute Q&A for which you can send in questions prior to or during the webinar. Use the registration form to send in questions, e-mail them to marketing@qservegroup.com, or use the ‘Question Tab’ during the webinar.
The recording and slides will be shared with all registrants after the webinar.
Your Qserve hosts: